Compliance officials have a great deal to worry about. They are judged by results and loaded with stress over the latest changes in government guidance documents and internal budget pressures. They need to continually update their programs to stay abreast of those developments, including revisions that target in-house processes to encourage disclosures from whistleblowers. Failure to provide for such revisions places both a company and individuals at risk Whistleblower Protection Expanded and Includes Rewards In response…
Saturday, December 1, 2012 Daily Archives
Where’s the Viral Marketing When Spreading Information on Actual Viruses?
The importance of the Centers for Disease Control and Prevention (CDC, www.cdc.gov) in the tracking and treatment of viruses such as the influenza virus cannot be underestimated. It is a first line of defense against an influenza pandemic as well as a way to analyze seasonal influenza outbreaks to make certain that they do not deviate from their normal seasonal and geographic patterns. The CDC seeks to communicate with the American public through a wide variety of media. To its…
Biopharmaceuticals On Demand
By 2016, five of the top 10 biopharmaceuticals are expected to be monoclonal antibodies (MAbs). Follow-on (biosimilar) versions of those blockbusters will most likely become available in later years due to patent expiry and the introduction of legislation for biosimilars around the world. Personalized therapies will drive the fractionation of the biopharmaceutical market, trending biomanufacturing toward smaller batch sizes and campaign-based production schemes. A growing need for flexible, multipurpose, and cost-effective manufacturing will significantly affect the design of…
Global Marketplace
Cold-Chain Tracking Product: PakSense BIOmed XpressPDF package label Applications: Drugs, vaccines, and other temperature-sensitive biologics Features: Calibrated to NIST standards, PakSense BIOmed XpressPDF labels help companies monitor and record product package temperatures. The size of a sugar packet, each waterproof label features a USB connection that automatically generates PDF files. Unlike bulky recorders that read ambient conditions, a label sensor measures the temperature of the surface on which it is attached once a minute. Results can be read at a…
Lean Six Sigma
About 10 years ago as a vice president of Avecia Biologics, I wrote an article for an early issue of BioProcess International looking ahead at likely changes in biomanufacturing (1,2,3). For the best part of the intervening period, Avecia Biologics and Diosynth slugged it out in the marketplace, each trying to grow its contract manufacturing business at the expense of the other. But in a life-altering two-year period between 2009 and 2011, both companies saw their realities and…
Understanding the Patient Journey
The biopharmaceutical industry is abuzz with talk regarding a 2011 US Food and Drug Administration (FDA) guidance on human factors and the mitigation of user-based risk in the development of medical devices (1). As expected, his talk is often accompanied by a sense of anxiety. Device developers and the growing number of biomanufacturers developing combination drug–device products now need answers to usability questions they are hardly familiar with. Wrong answers may have direct (and troubling) implications from a…
Establishing Strategic Supplier Partnerships to Facilitate Manufacturing Success
In November 2009, Talecris Biotherapeutics announced an ambitious US$269 million expansion of its Clayton, NC, manufacturing facility. The company was subsequently purchased by Grifols, Inc. in 2011. Constructing a new facility with a state-of-the-art manufacturing process intended to generate clinical products involves top-notch project management, exceptional fortitude, and numerous supply chain decisions. Suppliers are often relied on to provide standard product support. When used effectively, they can be an invaluable resource beyond basic services. Additional support may include…
Biopharmaceutical Development and Production Week
IBC’s Biopharmaceutical Development and Production Week provides updates on current and emerging methods to improve your bioproduction capabilities and delivers strategies to help you overcome process challenges and accelerate production of the biopharmaceutical industry’s emerging new wave of monoclonal antibodies (MAbs) and novel molecules. Methods The Monday and Tuesday tracks provide a firm foundation in practical methods and strategies for specific unit operations. This can help you tackle some of the specific challenges in your job function. Implement process validation…
Toward Flexible Hybrid Facilities of the Future
As the bioprocessing industry has shifted away from traditional stainless steel bioreactors and vessels toward single-use technology, a new breed of manufacturing facilities has arisen. Flexible facilities take full advantage of traditional multiuse technologies and combine them with increasingly popular single-use technologies, offering an ability to mitigate risk and decrease manufacturing timelines. Although some companies have made the choice to remain strictly traditional (multiple use) and others have moved fully into single use, the flexible hybrid format gives…
Rapid Pharmaceutical Product Development
A Chemistry, Manufacturing, and Controls (CMC) Strategy Forum was held in January 2012 in San Francisco, CA, to examine the topic of rapid pharmaceutical product development. The purpose of this meeting was to promote an understanding of how best to increase the speed of product development, focusing on areas that improve chances of regulatory success while lessening the time it takes to get a product through development and onto the market. Participants also sought to identify and discuss…